CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Lamivudinedrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed metastatic (stage 4) adenocarcinoma of the colon with TP53 mutation/deletion (known loss of function) confirmed by CLIA-approved genetic test
  • ✓Measurable disease: ≥1 lesion accurately measured >20 mm with conventional techniques or >10 mm with spiral CT/MRI/calipers
  • ✓Resistant to or intolerant of 5FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab/panitumumab (if RAS wild type)
  • ✓Age ≥18 years
Key exclusion· 8
  • ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin C) prior to study entry
  • ✕Known brain metastases
  • ✕History of allergic reactions to compounds of similar chemical or biologic composition to lamivudine
  • ✕Uncontrolled intercurrent illness (active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, psychiatric illness/social situations limiting compliance)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03144804
NCT03144804Phase 2Completed
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A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer

Massachusetts General Hospital·interventional·Posted May 9, 2017·Updated Jun 6, 2024

In Brief

A Phase 2 clinical trial evaluating Lamivudine for Colorectal Cancer Metastatic. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This research study is studying a drug as a possible treatment for p53 mutant metastatic colorectal cancer. The drug involved in this study is: -Lamivudine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer Metastatic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 9, 2017
Enrollment StartOct 31, 2017
Primary CompletionMar 26, 2020
Study CompletionSep 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.1 years ago

Interventions

Lamivudinedrug

This drug may help prevent the growth and spread of the cancer cells to other parts of the body.